Class 2 Device Recall Nitro

• Date Initiated by Firm: June 14, 2024
• Date Posted: July 12, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2354-2024
• Recall Event ID: 94832
• Product Classification: Walker, mechanical - Product Code ITJ
• Product: Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791BL (Blue)
• Code Information: UPC: 822383019093 (791BL) All serial numbers beginning with 21S
• Recalling Firm/ Manufacturer: Medical Depot Inc.; 99 Seaview Blvd Fl 2; Port Washington NY 11050-4606
• For Additional Information Contact: SAME; 516-998-4600
• Manufacturer Reason for Recall: The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury
• FDA Determined Cause: Process control
• Action: Drive DeVilbiss Healthcare ( Drive ) issued Urgent Medical Device Recall letter on 6/14/24 to Distributors and End-Users via email. Letter states reason for recall, health risk and action to take: Please take the following three actions immediately: 1)Identify any inventory in your possession of 791BL and 791RD Nitro" Glide Knee Walkers containing serial numbers beginning with 21S, and ensure that they are placed in a location that will prevent sale or rental to an end user. 2) Go to https://www.recallrtr.com/kneewalker and enter your Unique Customer Code, located on the first page of this notice, directly below your address in bold type. Using that code on the website, you will be able to: a. Confirm the quantity of affected units in your possession (i.e., units that contain a serial number beginning with 21S); b. Request postage-paid mailing labels and packing material to return the affected units; c. Order replacement products; and d. Fill out a web form to acknowledge receipt of and compliance with the recall. If you experience any issues with the website or wish to communicate via phone, Drive has established a dedicated Customer Service phone number, (877) 206-1171, which will be available Monday through Friday, from 7:30 a.m. to 5:00 p.m. Central Time. You can also contact us via email regarding this recall at kneewalker@realtimeresults.net. 3) Please contact any customer/end user who purchased or rented an affected unit and provide them notice of and instructions for compliance with the recall. The recall website will also be enabled to assist end-users with registering for the recall, returning their affected unit, and receiving a replacement of the unit. On the website, you will also have the option to provide your customer list so that notification of end-users may be performed on your behalf.
• Quantity in Commerce: 875 units
• Distribution: Nationwide Foreign: Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.